Adaptation and Pilot Testing of a Mindfulness-Based Insomnia and Symptom Management Intervention for Women With Breast Cancer Receiving Treatment in Rural Medically Underserved Areas

Change in fatigue symptoms

Fatigue symptoms will be assessed using the 8-item PROMIS Fatigue Short Form. A raw score is calculated by summing all 8 items, yielding a total raw score that ranges from 8 to 40. The total raw score is then translated to a T-score, which is a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores indicated higher fatigue.

Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

Change in depressive symptoms

Depressive symptoms will be assessed using the 8-item PROMIS Depression Short Form. A raw score is calculated by summing all 8 items, yielding a total raw score that ranges from 8 to 40. The total raw score is then translated to a T-score, which is a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores indicate higher worse depressive symptoms.

Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

Change in anxiety symptoms

Anxiety symptoms will be assessed using the 8-item PROMIS Anxiety Short Form. A raw score is calculated by summing all 8 items, yielding a total raw score that ranges from 8 to 40. The total raw score is then translated to a T-score, which is a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores indicate worse anxiety symptoms.

Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

Change in pain severity

Pain severity will be assessed using the 11-item Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF consists of 4 items assessing pain severity, including worst, least, average, and current pain in the past week. Responses range from 0 (no pain) to 10 (pain as bad as you can imagine); items are averaged for a composite score that ranges from 0 to 10 with higher scores indicating high pain severity.

Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

Change in pain interference

Pain interference will be assessed using the 11-item Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF consists of 7 items assessing the degree to which pain has interfered with patients' daily activities in the past week. Responses range from 0 (does not interfere) to 10 (completely interferes); items are averaged for a composite score that ranges from 0 to 10 with higher scores indicating high pain interference.

Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

Change in mindfulness

Mindfulness will be assessed using the 10-item Cognitive and Affective Mindfulness Scale - Revised (CAMS-R). Items are summed to achieve a total score ranging from 10 to 40. Higher scores indicate higher levels of mindfulness.

Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

Change in self-efficacy for symptom management

Self-efficacy for symptom management will be measured using the 8-item PROMIS Self-Efficacy for Managing Chronic Conditions (Managing Symptoms) measure. A raw score is calculated by summing all 8 items, yielding a total raw score that ranges from 8 to 40. The total raw score is then translated to a T-score, which is a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores indicate higher self-efficacy for managing chronic conditions (managing symptoms).

Time frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)